Please Pass the Brownies – Uh – “Edible Retail Marijuana Products”

Colorado’s Department of Revenue recently published retail marijuana rules to implement that state’s Retail Marijuana Code (“RMC”). C.R.S. 12-43.4-101et seq. The rules took effect on October 15, and are the culmination of a change in Colorado law that began with an amendment to the Colorado Constitution providing for the regulation of marijuana “in a manner similar to alcohol.” Colo. Const. Art. XVIII, Section 16. In part, that amendment states:

Individuals will have to show proof of age before purchasing marijuana;

Selling, distributing, or transferring marijuana to minors and other individuals under the age of twenty-one shall remain illegal;

Driving under the influence of marijuana shall remain illegal;

Legitimate, taxpaying business people, and not criminal actors, will conduct sales of marijuana; and

Marijuana sold in this state will be labeled and subject to additional regulations to ensure that consumers are informed and protected.

The RMC defines “Marijuana products” to mean “concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures” (emphasis added). The RMC authorizes the issuance of regulations governing retail marijuana that must include certain labeling requirements.

In accord with the above, the Permanent Rules Related to the Colorado Retail Marijuana Code define a “Retail Marijuana Product” to mean “concentrated Retail Marijuana and Retail Marijuana Product that are comprised of Retail Marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible product, ointments, and tinctures” (emphasis added). The rules further define an “Edible Retail Marijuana Product” to mean “any Retail Marijuana Product which is intended to be consumed orally, including but not limited to, any type of food, drink, or pill” (emphasis added). The rules require the following information to be affixed to every container holding an edible retail marijuana product:

Ingredient List: A list of all ingredients used to manufacture the Edible Retail Marijuana Product; which may include a list of any potential allergens contained within.

Statement Regarding Refrigeration: If the Retail Marijuana Product is perishable, a statement that the Retail Marijuana Product must be refrigerated.

Serving Size Statement: “The standardized serving size for this product includes no more than ten milligrams of active THC.”

Statement of Expiration Date: A product expiration date, for perishable Retail Marijuana Product, upon which the product will no longer be fit for consumption, or a use-by-date, upon which the product will no longer be optimally fresh. Once a label with a use-by or expiration date has been affixed to a Container holding a Retail Marijuana Product, a Licensee shall not alter that date or affix a new label with a later use-by or expiration date.

The rules permit, but do not require, edible products to bear information regarding a product’s compatibility with dietary restrictions, and a nutritional fact panel that, if included, must be based on the number of THC servings within the container.

The rules include provisions that appear intended to minimize the potential for cross-contact with food products that do not contain marijuana, and to minimize consumer confusion with respect to such products. For example, a Retail Marijuana Products Manufacturing Facility is prohibited from handling Retail Marijuana Products in a location that is operating as a retail food establishment or a wholesale food registrant. Also, such a facility cannot label a Retail Marijuana product in a way that could cause confusion as to whether that product is a trademarked food product. Finally, retail marijuana stores cannot sell or give away any consumable product that is not a retail marijuana product, including food products or non-alcohol beverages that are not Retail Marijuana Products.

Marijuana-infused foods have been available in Colorado for some time (see here), but were previously available only as medical marijuana. Increased availability under the new rules is certain to give rise to ever more creative edible concoctions (see here). It’s hard to imagine that the coming explosion of packaged marijuana-infused foods isn’t causing some discomfort at FDA, given the agency’s recent targeting of caffeinated foods. The recently issued DOJ memorandum providing guidance on marijuana enforcement makes clear that the sale and use of marijuana and marijuana containing products remains illegal under Federal law, and that the memorandum “does not alter in any way the Department’s authority to enforce federal law… regardless of state law.” However, the memorandum suggests that the federal government does not intend to interfere with retail marijuana operations conducted in accord with a “strong and effective state regulatory system.” Further, the memorandum does not explicitly address applicability and enforcement of the FDC Act to such products. The result could be odd in at least one respect: in states such as Colorado, a brownie laced with hash may be easier to come by than one containing added caffeine.